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| Product NDC Code | 0338-0048 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sodium chloride |
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| Type | Generic | ||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | IRRIGATION | ||||||||
| Dosage Form | IRRIGANT | ||||||||
| RxCUI drug identifier | 486515 | ||||||||
| Application Number | NDA017427 | ||||||||
| Labeler Name | Baxter Healthcare Corporation | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 0.9% Sodium Chloride Irrigation, USP Each 100 mL contains: 900 mg Sodium Chloride, USP. No antimicrobial agent has been added. pH 5.5 (4.5 to 7.0). Osmolarity 308 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.
Spl product data elements
Usually a list of ingredients in a drug product.SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label Container Label 2F7124 NDC 0338-0048-04 1000 mL Baxter Logo Not for Injection 0.9% Sodium Chloride Irrigation, USP Each 100 mL contains: 900 mg Sodium Chloride, USP. No antimicrobial agent has been added. pH 5.5 (4.5 to 7.0). Osmolarity 308 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle. Isotonic solution for irrigation only. Dosage and Administration: As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only. Recommended storage: Room temperature (25°C). Avoid excessive heat. PL 325 plastic Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA LOT EXP 07-09-00-0243 Bar Code Position Only* 303380048045 FPO (91)0709000243 0.9% Sodium Chloride Irrigation, USP Representative Container Label
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Recommended storage: Room temperature (25°C). Avoid excessive heat.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API